Biosimilari u liječenju upalnih reumatskih bolesti

master's thesis

• Title (english): Biosimilars for treating inflammatory rheumatic conditions
• Author: Lucija Jurić
• Mentor: Porin Perić (mentor)
• Committee member: Nadica Laktašić Žerjavić (predsjednik povjerenstva)
• Committee member: Jasenka Markeljević (član povjerenstva)
• Committee member: Porin Perić (član povjerenstva)
• Granter: University of Zagreb; School of Medicine; (Department of Physical Medicine and General Rehabilitation); Zagreb
• Defense date and country: 2019-07-12, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Clinical Medical Sciences; Physical Medicine and Rehabilitation

Abstract

Biosimilar ili biosličan lijek kopija je originalnog biološkog lijeka kojem je dokazano sličan, ali ne i identičan u pogledu kakvoće, biološke aktivnosti, sigurnosti primjene i djelotvornosti. Biološki lijekovi značajno su doprinijeli efikasnosti i imaju važnu ulogu u liječenju upalnih reumatskih bolesti, a biosimilarima se, zbog njihove niţe cijene, nastoji povećati dostupnost ove terapije. Zbog složenosti bioloških lijekova i biosimilara njihova je proizvodnja veoma složen proces, a da bi bili odobreni moraju zadovoljiti rigorozne kriterije. Isto tako, nakon odobrenja iznimno je važno njihovo praćenje. Imunogeničnost je problem svakog biološkog lijeka, ne samo biosimilara. Problem koji zabrinjava stručnjake je pitanje razloga i sigurnosti zamjene biološkog lijeka alternativnim biološkim lijekom, referentnog biološkog lijeka njegovim biosimilarom ili obrnuto te jednog biosimilara drugim biosimilarom istog referentnog lijeka. Biosimilari koji se upotrebljavaju u reumatologiji većinom su ispitani samo na jednoj indikaciji te na temelju ekstrapolacije indikacija mogu biti indicirani i u drugim stanjima za koje je odobren referentni lijek. Stručnjaci se slažu da su biosimilari ravnopravni originalnim biološkim lijekovima, ali većina ne preporuča multiple zamjene, zamjene iz nemedicinskih razloga te da se zamjene provodi bez znanja liječnika koji propisuje lijek. I pacijenti i zdravstveni djelatnici imaju podijeljene stavove u vezi biosimilara te je potrebno provoditi edukacije o njima. Zapažen je utjecaj nocebo efekta prilikom upotrebe biosimilara.

Abstract (english)

Biosimilar is a copy of original biologic therapeutic with which it is proved to be similar, but not identical in quality, biological activity, safety, and efficacy. Biologics have significantly contributed to efficacy and have a major part in treating inflammatory rheumatic conditions and biosimilars, because of their low price, strive to increase the availability of this therapy. Because of the complexity of biologics and biosimilars, their manufacturing is a very complicated process, and for their approval they need to fulfill rigorous criteria. After the approval, it is important to keep track of the drug. All biologics have a problem with immunogenicity, not just biosimilars. The problem that concerns experts is the question of the reason and safety of switching biologic with alternative biologic, biooriginator with biosimilar or vice versa and one biosimilar with another biosimilar of the same biooriginator. Biosimilars used in rheumatology are mainly tested in one indication and with extrapolation of an indication, then they can be indicated in other conditions for which the referent drug has been approved. Experts agree that biosimilars and biooriginators are equal, but most of them do not recommend multiple switches, switches with non-medical reasons and switches without knowledge of the doctor that prescribed the therapy. Both patients and physicians have divided attitudes towards biosimilars and education about them is necessary. The influence of the nocebo effect is noticed with the use of biosimilars.

• Keywords: biološki lijekovi; biosimilari; upalne reumatske bolesti; zamjena; zamjenjivost; imunogeničnost; ekstrapolacija; nocebo efekt
• Keywords (english): biologic therapeutics; biosimilars; inflammatory rheumatic conditions; switching; interchangeability; immunogenicity; extrapolation; nocebo effect
• Language: croatian
• URN:NBN: urn:nbn:hr:105:304367
• Study programme: Title: Medicine; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: doktor/doktorica medicine (doktor/doktorica medicine)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2020-01-08 15:16:58